The world’s largest biotech company has engaged with Qantas to fast-track a mass shipment of the first COVID-19 testing kits into Australia from the United States.
Allison Rossiter, managing director of Roche Diagnostics Australia told MHD Supply Chain News that the first shipment among 100,000 new coronavirus testing kits arrived in Sydney late evening on Tuesday 17th March.
“Given the unprecedented demand for COVID-19 tests locally, we can confirm that the first shipment of the new cobas SARS-CoV-2 tests to leave the Roche US warehouse, was to Australia,” she said.
Allison said the test kits were then loaded onto Toll trucks for distribution to locations of greatest need across the country, ensuring people at the highest risk of COVID-19 have access to these tests.
The development of the new cobas SARS-CoV-2 Test by the global pharmaceuticals and diagnostics company was significantly expedited to support the urgent need for patient testing during the novel coronavirus (COVID-19) pandemic.
The assay has been developed in Pleasanton, US, and is being produced in Branchburg, US. The system on which this assay is run is produced in Rotkreuz, Switzerland.
“Components such as consumables and reagents are part of our global supply chain network,” Allison said.
On 31 January 2020, the Therapeutic Goods Administration (TGA) granted an emergency exemption to allow tests for SARS-CoV-2 to be used for the COVID-19 public health emergency.
On Thursday, 12 March 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorisation (EUA) for the cobas SARS-CoV-2 Test. This authorisation was permitted to enable the rapid deployment of the new tests, to assist in the detection and diagnosis of the SARS-CoV-2 virus during the COVID-19 pandemic.
Roche Australia has changed its warehouse and supply chain operations to ensure all orders for SARS-CoV-2 tests are currently on ‘urgent delivery’.
Allison said the company is going to the limits of its production capacity to make sure large quantities of tests are available for affected countries.
“At our current rate, we can supply millions of new tests each month,” she said.
“We are working around the clock to increase that quantity as we recognise the importance of countries being able to access these critical tests quickly for their citizens.”
The cobas SARS-CoV-2 Test detects the virus from patient samples collected via a swab (not provided by Roche) that is then run on the high throughput cobas 6800 instrument, which are available in a number of laboratories across all Australian states.
Results are available in around 3 hours and each system can generate over 1,000 results in 24 hours.